Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension



Status:Active, not recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 85
Updated:10/27/2018
Start Date:September 2, 2016
End Date:September 29, 2021

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A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease

The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and
well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease
(CVD).


Inclusion Criteria:

- Subject has provided informed consent before initiation of any study-specific
activities/procedures

- Subject has completed FOURIER (Study 20110118) while still receiving assigned
investigational product.

Exclusion Criteria:

- Investigational product was permanently discontinued during FOURIER for any reason,
including an adverse event or serious adverse event

- Subject is currently receiving treatment in another investigational device or drug
study, or ended treatment on another investigational device or drug study(ies) within
less than 4 weeks. Other investigational procedures while participating in this study
are excluded

- Subject is not likely to be available to complete protocol-required study visits or
procedures and/or to comply with required study procedures to the best of the
subject's and investigator's knowledge

- Subject has a history or evidence of any other clinically significant disorder,
condition, or disease that, in the opinion of the investigator or Amgen physician, if
consulted, would pose a risk to subject safety or interfere with the study evaluation,
procedures, or completion

- Subject has a known sensitivity to any of the active substances or excipients (eg,
carboxymethylcellulose) to be administered during dosing

- Female subject is pregnant or breastfeeding or is planning to become pregnant or
planning to breastfeed during treatment with evolocumab and within 15 weeks after the
end of treatment with evolocumab

- Female subjects of childbearing potential who are not willing to use an acceptable
method(s) of effective birth control during treatment with evolocumab and for an
additional 15 weeks after the end of treatment with evolocumab are excluded
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